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NCT01332968 · ClinicalTrials.gov registry record · Phase 3
A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,401
- Enrollment target
NCT01332968 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,401 participants.
The verdict
NCT01332968, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,401 participants
- Enrollment target
Study Summary
This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Vincristine
- DRUG Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,401 participants |
| Start Date | 2011-07-06 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01332968
The ClinicalTrials.gov registry entry for NCT01332968 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,401 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT01332968 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01332968 about?
NCT01332968 is a clinical study titled "A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)". This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin...
What is the current status of trial NCT01332968?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,401 participants. The study started on 2011-07-06. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT01332968?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Vincristine (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT01332968?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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